Intraoperative Music and Propofol Consumption in Breast Surgery

NCT07687095 | Not Yet Recruiting

• 1 other identifier: MUSIC-BREAST-RCT-01
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to find out whether listening to music during surgery can reduce the amount of propofol, an anesthesia medicine, needed in patients having elective breast surgery. Patients who agree to take part will be randomly assigned to one of two groups. One group will listen to music of their choice through headphones during anesthesia and recovery. The other group will receive standard anesthesia care without music. All patients will receive routine anesthesia monitoring, including a monitor that helps assess the depth of anesthesia. The main outcome of the study is the total amount of propofol used during surgery. The study will also look at anesthesia depth values, use of other anesthesia medicine, blood pressure and heart rate, time spent in the recovery unit, nausea and vomiting after surgery, and patient satisfaction.

Conditions

Anesthesia , Analgesia; Breast Surgery

Keywords

Intraoperative Music; Propofol Consumption; Bispectral Index; Total Intravenous Anesthesia

Outcome Measures

Primary Outcomes (1)

• Total Propofol Consumption

  Total amount of propofol administered during anesthesia, normalized to body weight and expressed as mg/kg. Propofol consumption will be obtained from the target-controlled infusion pump records.

  From anesthesia induction to the end of surgery, assessed up to 6 hours.

Secondary Outcomes (9)

• Bispectral Index Values

  From anesthesia induction to the end of surgery, assessed up to 6 hours.

• Remifentanil Consumption

  From anesthesia induction to the end of surgery, assessed up to 6 hours.

• Mean Heart Rate

  From anesthesia induction to the end of surgery, assessed up to 6 hours.

• Mean Systolic Arterial Pressure

  From anesthesia induction to the end of surgery, assessed up to 6 hours.

• Mean Diastolic Arterial Pressure

  From anesthesia induction to the end of surgery, assessed up to 6 hours.

Study Arms (2)

Intraoperative Music Group

EXPERIMENTAL

Participants in this group will receive standard anesthesia care and will listen to self-selected music through noise-cancelling headphones from immediately before anesthesia induction until discharge from the post-anesthesia care unit.

Behavioral: Intraoperative Music

Control Group

NO INTERVENTION

Participants in this group will receive standard anesthesia care without intraoperative music.

Interventions

Intraoperative Music BEHAVIORAL

Participants assigned to the music group will listen to self-selected music through noise-cancelling Bluetooth headphones from immediately before anesthesia induction until discharge from the post-anesthesia care unit. Music volume will be set at approximately 50-60 dB. Standard anesthesia care will be provided according to the study protocol.

Intraoperative Music Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 70 years
• American Society of Anesthesiologists physical status I or II
• Scheduled to undergo elective breast surgery with an estimated surgical duration of 45 to 180 minutes
• Planned anesthesia technique is total intravenous anesthesia
• Able to understand Turkish and communicate verbally
• Able to read and write and provide written informed consent
• Clinically normal hearing function and no ear, nose, or throat condition that prevents headphone use

You may not qualify if:

• Diagnosed unilateral or bilateral hearing loss or use of a hearing aid
• Current psychiatric disease or regular use of psychotropic medication, including antidepressants, antipsychotics, anxiolytics, or hypnotics
• Diagnosis of chronic pain syndrome or chronic use of opioids, pregabalin, or gabapentin
• Neurological disease that may affect BIS interpretation, such as epilepsy, dementia, stroke sequelae, or Parkinson disease
• Known allergy or contraindication to propofol, remifentanil, or rocuronium
• Morbid obesity, defined as body mass index greater than 40 kg/m²
• History of active alcohol or substance dependence
• Pregnancy or breastfeeding
• Emergency surgery or reoperation
• Planned addition of regional anesthesia in the preoperative period
• Refusal to participate in the study or refusal to sign the informed consent form

Sponsors & Collaborators

• Uludag University: lead

Study Sites (1)

Bursa Uludag University Faculty of Medicine

Bursa, Bursa, 16059, Turkey (Türkiye)

Location

Related Publications (3)

• Li G, Yu L, Yang Y, Deng J, Shao L, Zeng C. Effects of Perioperative Music Therapy on Patients with Postoperative Pain and Anxiety: A Systematic Review and Meta-Analysis. J Integr Complement Med. 2024 Jan;30(1):37-46. doi: 10.1089/jicm.2022.0803. Epub 2023 Aug 30.

  PMID: 37646752 BACKGROUND

• Hole J, Hirsch M, Ball E, Meads C. Music as an aid for postoperative recovery in adults: a systematic review and meta-analysis. Lancet. 2015 Oct 24;386(10004):1659-71. doi: 10.1016/S0140-6736(15)60169-6. Epub 2015 Aug 12.

  PMID: 26277246 BACKGROUND

• Fu VX, Oomens P, Klimek M, Verhofstad MHJ, Jeekel J. The Effect of Perioperative Music on Medication Requirement and Hospital Length of Stay: A Meta-analysis. Ann Surg. 2020 Dec;272(6):961-972. doi: 10.1097/SLA.0000000000003506.

  PMID: 31356272 BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Selcan Akesen, MD

CONTACT

+90 224 295 32 74; selcanakesen@uludag.edu.tr

Gokce Kizilkale Kayikci, MD

CONTACT

+90 224 295 3124; gkizilkale@uludag.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The anesthesia team will not be blinded to group allocation. The surgeon, post-anesthesia care unit staff, and outcome assessor will not be informed of the assigned group.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomized into two parallel groups: intraoperative music plus standard anesthesia care or standard anesthesia care alone.

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: July 7, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)